Poor therapeutic adherence is a major issue faced by physicians today. This paper summarizes the adherence rates with oral bisphosphonate (OBP) treatment in clinical practice and their impact on clinical ... [more ▼]

Poor therapeutic adherence is a major issue faced by physicians today. This paper summarizes the adherence rates with oral bisphosphonate (OBP) treatment in clinical practice and their impact on clinical outcomes. Studies systematically demonstrated that overall compliance and persistence with OBPs among osteoporotic women are poor. Although extending dosing intervals improved adherence, the gains are suboptimal. Most importantly, low compliance and persistence rates consistently resulted in increased rates of fractures. The results emphasize the importance of adherence to treatment to achieve optimal antifracture efficacy. There is an urgent need to implement strategies and to encourage physicians to take measures that increase patients' awareness of the need to use osteoporosis medications as directed in order to benefit from them fully. [less ▲]

The objective of the study assess the relationship between bone mineral density (BMD) loss over time and fracture incidence in postmenopausal women. This is a posthoc analysis that includes women from the ... [more ▼]

The objective of the study assess the relationship between bone mineral density (BMD) loss over time and fracture incidence in postmenopausal women. This is a posthoc analysis that includes women from the placebo group of two large randomized controlled trials having assessed the efficacy of a new anti-osteoporotic drug. BMD was assessed every 6 months during 3 years at the lumbar spine, the femoral neck and the total proximal femur. Vertebral fractures were assessed using a semiquantitative method. Hip fractures were based on written documentation. All patients received calcium and vitamin D. In the present study that included 1,775 patients (with complete data at baseline and after 3 years), the logistic regression analysis, adjusted for covariates, showed that 3-year change in lumbar BMD was not statistically associated with the new vertebral fractures after 3 years. However, femoral neck and total proximal femur BMD changes was statistically correlated with the incidence of new vertebral fractures (P < 0.001). When considering change in BMD after the first year of follow-up, a decrease in total proximal femur BMD was statistically associated with an increase in the incidence of new vertebral fractures during the last 2 years of follow-up (P = 0.048). The 3-year change in femoral neck and total proximal BMD was statistically correlated with the incidence of hip and fragility fracture after 3 years (all P < 0.001). In this elderly osteoporotic population receiving calcium and vitamin D, a decrease in hip BMD after 1 or 3 year of follow-up, is associated with an increased risk of fracture incidence. However, spine BMD changes do not influence vertebral fracture incidence. [less ▲]

BACKGROUND: Following hip fracture, pharmacologic treatment can reduce the rate of subsequent fragility fractures. The objective of the present study was to assess the proportion of patients who are ... [more ▼]

BACKGROUND: Following hip fracture, pharmacologic treatment can reduce the rate of subsequent fragility fractures. The objective of the present study was to assess the proportion of patients who are managed with bisphosphonates or selective estrogen-receptor modulators after hip fracture and to evaluate, among those managed with alendronate, the twelve-month compliance and persistence with treatment. METHODS: Data were gathered from health insurance companies and were collected by AIM (Agence Intermutualiste) for the Belgian National Social Security Institute (INAMI). We selected all postmenopausal women who had been hospitalized for a hip fracture between April 2001 and June 2004 and had not been previously managed with bisphosphonates. Patients who had received alendronate treatment after the hip fracture were categorized according to their formulation use during the follow-up study (daily, weekly, daily followed by weekly, or weekly followed by weekly). Compliance at twelve months was quantified with use of the medication possession ratio (i.e., the number of days of alendronate supplied during the first year of treatment, divided by 365). Persistence with prescribed treatment was calculated as the number of days from the initial prescription to a lapse of more than five weeks after completion of the previous prescription refill. The cumulative treatment persistence rate was determined with use of Kaplan-Meier survival curves. RESULTS: A total of 23,146 patients who had sustained a hip fracture were identified. Of these patients, 6% received treatment during the study period: 4.6% received alendronate, 0.7% received risedronate, and 0.7% received raloxifene. Bisphosphonate treatment was dispensed to 2.6% and 3.6% of the patients within six months and one year after the occurrence of the hip fracture, respectively. Among women who received alendronate daily (n = 124) or weekly (n = 182) and were followed for at least one year after the hip fracture, the twelve-month mean medication possession ratio was 67% (65.9% in the daily group and 67.7% in the weekly group). The analysis of persistence with treatment included a total of 726 patients (142 in the daily group, 261 in the weekly group, and 323 in the switch group). At twelve months, the rate of persistence was 41% and the median duration of persistence was 40.3 weeks. CONCLUSIONS: The vast majority of patients who experience a hip fracture do not take anti-osteoporotic therapy after the fracture. Furthermore, among patients who begin alendronate treatment after the fracture, the adherence to treatment decreases over time and remains suboptimal. [less ▲]

Adherence is now one of the major issues in the management of osteoporosis and several papers have suggested that vertebral fractures might be increased in patients who do not follow appropriately their ... [more ▼]

Adherence is now one of the major issues in the management of osteoporosis and several papers have suggested that vertebral fractures might be increased in patients who do not follow appropriately their prescriptions. This paper relates the strong relationship existing between adherence to anti-osteoporosis treatment and the risk of subsequent hip fracture. INTRODUCTION: A study was performed to investigate adherence to bisphosphonate (BP) therapy and the impact of adherence on the risk of hip fracture (Fx). METHODS: An exhaustive search of the Belgian national social security database was conducted. Patients enrolled in the study were postmenopausal women, naive to BP, who received a first prescription of alendronate. Compliance at 12 months was quantified using the medication possession ratio (MPR). Persistence was calculated as the number of days from the initial prescription to a gap of more than 5 weeks after completion of the previous refill. A logistic regression model was used to estimate the impact of compliance on the risk of hip fracture. The impact of persistence on hip fracture risk was analysed using the Cox proportional hazards model. RESULTS: The mean MPR at 12 months was significantly higher among patients receiving weekly (n = 15.021) compared to daily alendronate (n = 14,136) (daily = 58.6%; weekly = 70.5%; p < 0.001). At 12 months, the rate of persistence was 39.45%. For each decrease of the MPR by 1%, the risk of hip Fx increased by 0.4% (OR: 0.996; CI 95%: 0.994-0.998; p < 0.001). The relative risk reduction for hip Fx was 60% (HR: 0.404; CI 95%: 0.357-0.457; p < 0.0001) for persistent compared to non-persistent patients. CONCLUSION: These results confirm that adherence to current therapeutic regimens remains suboptimal. [less ▲]

Adherence to anti-osteoporosis medications is currently low and is associated with poor anti-fracture efficacy. This manuscript reviews the potential design of clinical studies that aim to demonstrate ... [more ▼]

Adherence to anti-osteoporosis medications is currently low and is associated with poor anti-fracture efficacy. This manuscript reviews the potential design of clinical studies that aim to demonstrate improved adherence, with new chemical entities to be used in the management of osteoporosis. Introduction Several medications have been unequivocally shown to decrease fracture rates in clinical trials. However, in real life settings, long-term persistence and compliance to anti-osteoporosis medication is poor, hence decreasing the clinical benefits for patients. Methods An extensive search of Medline from 1985 to 2006 retrieved all trials including the keywords osteoporosis, compliance, persistence or adherence followed by a critical appraisal of the data obtained through a consensus expert meeting. Results The impact of non-adherence on the clinical development of interventions is reviewed, so that clinicians, regulatory agencies and reimbursement agencies might be better informed of the problem, in order to stimulate the necessary research to document adherence. Conclusion Adherence to therapy is a major problem in the treatment of osteoporosis. Both patients and medication factors are involved. Adherence studies are an important aspect of outcomes studies, but study methodologies are not well developed at the moment and should be improved. Performing adherence studies will be stimulated when registration authorities accept the result of these studies and include the relevant information in Sect. 5.1 of the summary of product characteristics. Reimbursement authorities might also consider such studies as important information for decisions on reimbursement. [less ▲]